CSV Technical Lead

10 hours ago

Bengaluru, Karnataka, India beBeeCsv Full time ₹ 7,50,000 - ₹ 15,00,000

About the Role

We are seeking a detail-oriented professional to fill the position of CSV Specialist. The ideal candidate will work closely with cross-functional teams, contribute to audits and inspections, and provide expert guidance on CSV processes.

This role plays a key part in maintaining the quality and compliance of our IT systems by developing, executing, and maintaining validation protocols and documentation to ensure adherence to regulatory standards.

Key Responsibilities:

  1. Develop and maintain Computer System Validation (CSV) protocols and reports that meet FDA, EMA, and other regulatory requirements.
  2. Collaborate with cross-functional teams to deliver high-quality CSV documentation in a timely manner.
  3. Prepare and update user manuals, SOPs, and other technical documentation related to CSV processes.
  4. Execute CSV activities including risk assessments, validation testing, and documentation review.
  5. Support audits and regulatory inspections by providing relevant CSV documentation and participating in audit response efforts.
  6. Stay updated with evolving industry regulations and ensure company practices remain aligned with current best practices.
  7. Train internal teams and stakeholders on CSV processes and documentation expectations.
  8. Drive continuous improvement efforts to enhance CSV processes and document efficiency.
  9. Maintain accurate records and validation documentation for all CSV-related activities and projects.
  10. Provide expert CSV guidance to internal departments and stakeholders as required.
  11. Perform validation executions either remotely or through on-site visits, depending on client requirements.

Requirements:

  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • Proven experience in CSV within regulated industries like pharmaceuticals or healthcare.
  • Strong understanding of GxP compliance, FDA, EMA guidelines, and related industry standards.
  • Exceptional communication skills with the ability to produce clear, concise, and structured documentation.
  • Detail-oriented, with excellent analytical and problem-solving skills.
  • Capable of working independently as well as collaboratively in a team environment.
  • Flexibility to travel for client visits or perform remote validation execution as needed.

What We Offer

  • A dynamic and collaborative work environment.
  • The opportunity to work on challenging projects and contribute to the growth of the company.
  • A competitive compensation package and opportunities for professional development.

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